FDA Adverse Event
Injury
Summary report: N
UNKNOWN HIP SYSTEM
MDR report key: 2831137
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02182
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION, NO ADD¿L INFO IS AVAILABLE AT THIS TIME. IF ADD¿L INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM, PLEASE BE AWARE THAT THIS OFFICE HAS BEEN RETAINED TO REPRESENT THE FOLLOWING INDIVIDUAL IN RELATION TO CLAIM FOR PERSONAL INJURY RESULTING FROM THE IMPLANTATION OF STRYKER¿S RECALLED REJUVENATE OR ABG II HIP DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP SYSTEM | IMPLANT | LZO | STRYKER ORTHOPAEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |